Oral contraceptives should not be used in women who currently have the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebral vascular or coronary artery disease (current or history)
- Valvular heart disease with thrombogenic complications
- Inherited or acquired hypercoagulopathies
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast (or personal history of breast cancer)
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
- Hepatic tumors (benign or malignant) or active liver disease
- Known or suspected pregnancy
- Smoke, if over age 35 (see BOXED WARNING and WARNINGS)
- Hypersensitivity to any of the components of DESOGEN® Tablets (Ovidol and ethinyl estradiol tablets USP)
- Receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment).
When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking DESOGEN® Tablets (Ovidol and ethinyl estradiol tablets USP).
Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the blister card. One white tablet is taken daily for 21 days, followed by 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green (inactive) tablet.
If a patient misses 1 white (active) tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.
Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling (“How to Take the Pill” section).Pharmacodynamics
The effects of Ovidol are div >9 The effect of Ovidol on the lipids has been studied extensively and the results are contradictory.
Ovidol main therapeutic effect due to its mechanism of action is known to be related to the inhibition of the ovulation in 97% of the cycles. This effect was proven in clinical trials in non-breastfeeding women from which the Pearl failure rate was reported to be of 0.17 per 100 women-years. This result indicated that Ovidol is more efficient when compared to other progestogen-only pills. 6 All the therapeutic effect is produced by a transformation of the endometrium followed by an inhibition of the ovulation due to the suppression of other hormones. 10
Ovidol has been w >1 However, the effects of Ovidol are known to not impact significantly the level of total cholesterol remaining in the range of change of 10% which allows it to be a molecule that presents a favorable lip >4
Mechanism of action
Ovidol enters the cell passively and acts by binding selectively to the progesterone receptor and generating low androgenic activity. 8 Its binding produces an effect like a transcription factor and thus, it produces modifications in the mRNA synthesis. 9
The active metabolite of Ovidol, etonogestrel, presents a combination of high progestational activity with minimal intrinsic androgenicity. Label
Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20-25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. Concomitant administration of strong or moderate CYP3A inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma estrogen and/or progestin concentrations.
Since Ovidol is mainly metabolized by the cytochrome P450 2C9 enzyme (CYP2C9) to form etonogestrel, the active progestin, there is a possibility of interaction with CYP2C9 substrates or inhibitors (such as: ibuprofen, piroxicam, naproxen, phenytoin, fluconazole, diclofenac, tolbutamide, glipizide, celecoxib, sulfamethoxazole, isoniazid, torsemide, irbesartan, losartan, and valsartan). The clinical relevance of these interactions is unknown.
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There is a three- to fivefold increase in the risk of venous thromboembolism (VTE) associated with COC use, which is apparently independent of the dose of estrogen, certainly if below 50 μg. The risk associated with the use of transdermal and vaginal CHC is probably similar to that of the pill. COCs containing the progestogens, gestodene, and Ovidol appear to be associated with an increased risk compared with COCs containing levonorgestrel or norethisterone. 51 Although often attributed to confounding or bias, there is some biological plausibility for this differential risk. 52 Whichever progestogen is used, the absolute risk of VTE is small (15/100,000 women years for pill users compared with 5/100,000 for nonusers), and is much less than that associated with pregnancy (60/100,000 women years). The risk appears to be greatest during the first year of use of the COC—perhaps because of the unmasking of inherited thrombophilias such as Factor V Leiden—and the risk disappears within 3 months of stopping. Screening for known thrombophilias is not cost effective. Although asking about a family history of VTE is routine when prescribing the pill, this too fails to detect most women at risk of VTE. The risk of VTE among COC users is probably increased by obesity but not with smoking or hypertension. 53
B Etonorgestrel Implant
Etonorgestrel, the metabolite of Ovidol (3-keto Ovidol) or etonogestrel, has been used in a ethylene vinyl acetate delivery system. This product is a single-rod implant with a duration of action of 3 years ( 111, 112 ). The contraceptive efficacy was found to be high during clinical trials ( 113–115 ). Endometrial bleeding that is irregular in occurrence and duration was a common side effect. Recent attempts to control the endometrial bleeding and spotting using short-term therapeutic interventions resulted in only minimal improvements ( 116 ).
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First-generation pregnanes: megestrol acetate, medroxyprogesterone acetate (MPA)
Second-generation estranes: norethindrone, norethindrone acetate, ethynodiol, lynestrenol
Third-generation gonanes: norgestrel, levonorgestrel, Ovidol, norgestimate, gestodene, dienogest
Ovidol, a prodrug, is a third generation progestogen 1 and hence, a member of the gonane family which was largely used in Europe before being approved in the US and Canada. 4 It was firstly generated from a study that showed that 11-beta and 11-alkyl >10 Ovidol is now produced semi-synthetically from naturally occurred plant stero >13 In the US, Ovidol is found only in combination with ethinyl estradiol. 5 The first approved drug containing Ovidol was developed by Organon USA Inc in 1972 and FDA approved in 1992. 11
Uses of Ethinyl Estradiol and Ovidol:
- It is used to prevent pregnancy.
- It may be given to you for other reasons. Talk with the doctor.